Kornimate/medical-research-clean huggingface dataset:
real world effectiveness of eptinezumab in participants with migraine

Conditions: Migraine

Summary: the purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (em) or chronic migraine (cm). these objectives include exploring the comparative effectiveness on patient reported outcomes.


Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine per international headache society (ihs) international classification of headache disorder (ichd)-3 guidelines at least 12 months prior to screening. * have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records. * be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known. * be willing to accept randomization to any of the possible study medications if allocated to that treatment arm. * be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application. exclusion criteria: * the participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients. * the participant has previous history of use of any of the study drugs (for example, eptinezumab, botox, erenumab, fremanezumab or galcanezumab). note that only previous botox use for treatment of migraine is exclusionary. prior use of botox for cosmetic purposes is allowed. * the participant has a diagnosis of cm and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation. * the participant has used opioids or butalbital-containing products greater than 4 days per month in the last month. other inclusion and exclusion criteria may apply.
does eliminating coffee avoid fibrillation?

Conditions: Atrial Fibrillation; Coffee

Summary: given both the increasing population impact of atrial fibrillation (af) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on af is of great clinical relevance. this study will evaluate the effect of randomly assigning participants undergoing cardioversion to coffee abstinence or coffee continuation over a 6 month period. this study will provide the first, randomized evaluation of coffee on af outcomes and will provide important information on whether or not coffee has any effect on af recurrence.

the purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (af) following cardioversion. as one of the most consumed beverages in the world, whether coffee has any effect on health outcomes is of considerable interest to physicians, scientists, and individual consumers. while significant data exist on the potential impact of coffee on many cardiometabolic parameters, there is conflicting data on any role of coffee on af. most studies so far have been observational in nature, limiting how much insight there is on the role of coffee on af. this study proposes to directly compare af outcomes for patients with af that abstain from coffee versus those that continue coffee consumption. a total of 200 af patients undergoing cardioversion will be enrolled in this study (100 per arm), and followed for up to 6 months post cardioversion. differences in af recurrence and symptoms will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * men or women ≥ 21 years of age * sustained af or atrial flutter (provided patient has a history of af) * planned/scheduled direct current electrical cardioversion * consumption greater than or equal to one cup of coffee per day sometime in the past 5 years * willing and able to comply with coffee abstinence or continuation for at least 6 months * life expectancy of at least 6 months * willing and able to return and comply with scheduled phone follow up visits * willing and able to provide written informed consent exclusion criteria: * established allergy or adverse reaction to coffee * stated inability to comply with coffee abstinence or continuation * af ablation in preceding 3 months or planned in next 3 months * recent cardiothoracic surgery in preceding 3 months * pregnancy or desire to get pregnant within next 6 months. * current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study * any other criteria, which would make the patient unsuitable to participate in this study as determined by the principal investigator (e.g., an uncontrolled drug and/or alcohol addiction)

Keywords: atrial fibrillation coffee afib
trial of obeticholic acid in patients with moderately severe alcoholic hepatitis (ah)

Conditions: Alcoholic Hepatitis

Summary: the main purpose of this study is to test the effectiveness of obeticholic acid when used in patients with moderately severe alcoholic hepatitis. the researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.


Eligibility criteria:
inclusion criteria: * individuals ≥ 21 years with a diagnosis of acute ah. the diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. a liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of ah cannot be made on clinical and laboratory criteria * moderate severity defined as meld score \> 11 and \< 20 * heavy alcohol consumption (defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment) * written informed consent * negative urine pregnancy test where appropriate * women of child bearing potential should be willing to practice contraception throughout the treatment period exclusion criteria: * significant active infection (e.g., sepsis, or spontaneous bacterial peritonitis; sbp). subjects can be reconsidered after the infection is under control. * serum creatinine \> 2.5 mg/dl * must not be receiving systemic steroids \> 1 week at the time of screening or any experimental medicines for ah * presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable). * participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
evaluation of the safety of compressive socks to treat venous insufficiency in patients with peripheral arterial disease

Conditions: Peripheral Arterial Disease; Venous Insufficiency

Summary: elastic compression stockings are recommended in the treatment venous insufficiency. degressive compressive stockings have been used for many decades and are characterized by a high pressure applied at the ankle and a decreasing pressure from the ankle to the knee. progressive compressive stockings were developed to have a maximal pressure at the calf. this concept is based on the calf pump role in the venous return. patients with pad (peripheral arterial disease) often suffer from venous insufficiency. but elastic compression stockings are strictly contraindicated for patients with pad because highest pressures on ankle could slow down the superficial microcirculation. on patients with pad and venous insufficiency, the progressive compressive stockings could be well indicated. strongest pressure at the calf should increase the pump effect and the muscle mechanical efficiency during the walk without deleterious effect.


Eligibility criteria:
inclusion criteria: * patient suffering from a pad (systolic pressure index ≥ 0,60 and ≤ 0,75) and having moderate venous insufficiency or classified as c1s to c4 using the ceap classification * age over 18 years * french health insurance * signed informed consent exclusion criteria: * hypertension not controlled or hypertensive crisis (risk of non reproducibility of spi and tbi) * diabetes * mediacalcosis (spi not computable) * inflammatory arterial diseases of the lower limb * permanent edema, lipedema and lymphedema * wound and fragile skin * phlegmatia coerulea dolens * septic thrombophlebitis * severe coronary artery disease * oozing and infectious skin diseases, skin ulcers * known hypersensitivity to components of the study compressive stockings

Keywords: peripheral arterial disease progressive compressive stockings
characteristics of empagliflozin initiators

Conditions: Type 2 Diabetes

Summary: empagliflozin, a sodium glucose cotransporter 2 (sglt-2) inhibitor, was launched in the united kingdom (uk) in august 2014. it can be expected that patients initiating empagliflozin may differ in their characteristics from patients initiating other glucose lowering drugs (glds) that have been on the market longer (e.g. patients may have poorer glucose control). therefore, the proposed study aims to characterize patients with t2dm in the uk initiating empagliflozin in terms of baseline characteristics, concomitant medications, and comorbidities compared to patients with type 2 diabetes mellitus (t2dm) initiating other sglt-2 inhibitors or other non-insulin glds. due to the mode of action, some patients taking empagliflozin have experienced weight loss in clinical trials. a theoretical possibility exists that empagliflozin may be used by patients without t2dm. therefore, this study also aims to assess the potential off-label use of empagliflozin compared to other non-insulin glds.

study design: cross sectional

Eligibility criteria:
inclusion criteria: all patients will be required to meet all of the following criteria: * at least 12 months of continuous registration prior to the index date in a practice contributing up to standard (uts) data to the clinical practice research datalink (cprd). infants younger than 1 year will not be required to have 12 months of continuous uts registration in the cprd. * a new user of one of the index prescriptions (empagliflozin, other sglt2 inhibitor, or non-insulin glds) or a fixed dose combination (fdc) with metformin. exclusion criteria: there is no exclusion criterion in this study.
hemodynamic changes in altitude adaptation

Conditions: Acute Mountain Sickness; High Altitude Pulmonary Edema; High Altitude Cerebral Edema

Summary: we use a new technology (nexfin from bmeye-inventive hemodynamics) to monitor cardiac output, blood pressure, fluid responsiveness, pulse oximetry, hemoglobin concentration, oxygen delivery in climbers during their process of acclimatization on a expedition to mount aconcagua.

several parameters will be recorded to analyze their influence on the adaptation to high altitude. such as, food composition, dietary supplements, water intake and output.

Eligibility criteria:
inclusion criteria: * no acute or chronic disease * body mass index : 20 - 30 exclusion criteria: * any preexisting disease that has a potential impact on physical performance such as: * pulmonary * cerebral * muscular * cardiac * vascular - diseases
antiresorptive effect of treatment with risedronate and vitamin d in postmenopausal patients

Conditions: Postmenopausal Osteoporosis; Hypovitaminosis D; Hyperparathyroidism

Summary: osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. recently, a high prevalence of hypovitaminosis d has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. an open-label, clinical trial was conducted in mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin d in improving bone mineral density, hyperparathyroidism, and hypovitaminosis d.

participants were selected from the climacteric clinic of the regional hospital "1ro de octubre-instituto de seguridad y servicios sociales para los trabajadores del estado (issste)", mexico. all participants voluntarily accepted to be part of the study and provided written informed consent.this study was approved by the institutional ethical committee of the hospital with registration number cofepris 17 ci 09005135 with the internal registration number 118.2021. every participant was clinically examined. their metabolic state was assessed by considering height, weight, body mass index (bmi) and the percentage of hb1ac. 33 patients were included among 40 to 78 years with the diagnosis of postmenopausal osteoporosis with associated hyperparathyroidism, hypovitaminosis d or both conditions. all the patients were treated for 6 months with 35 mg of risedronate and 2800 iu of vitamin d once a week, with additional daily supplementation of 4000 iu of vitamin d. statical analysis was performed using past 3.0 and graphpad prism 8.4.3. software. some statical parameters, such as arithmetic median (µ), and standard deviation (s.d.) were calculated using excel-word. graphics were constructed with graphpad prism 8.4.3 and tables were done in excel-word. the assigned α value for this study was \<0.05.

Eligibility criteria:
inclusion criteria: * participants with a diagnosis of postmenopausal osteoporosis or osteopenia. * participants with a diagnosis of hyperparathyroidism or hypovitaminosis d. * participants who accepted to participate and that provided informed consent. exclusion criteria: * participants with oncological pathologies. * participants with recent fractures. * participants with gastric intolerance or hypersensitivity to the drugs. * participants were under treatment with another antiresorptive or bone-forming drug, or if they were receiving treatment with thiazide diuretics, lithium, teriparatide or glucocorticoids. * participants with addison's disease, pheochromocytoma or depressive disorders.

Keywords: postmenopause postmenopausal osteoporosis hypovitaminosis d hyperparathyroidism risedronate osteopenia bone mineral density bone resorption
magnetic resonance imaging at different levels of magnetic intensity

Conditions: Cardiovascular Disease; Healthy

Summary: magnetic resonance imaging (mri) is a diagnostic tool that creates high quality images of the human body without the use of x-ray (radiation). mri uses different levels of magnetic fields to create images of the body and organs. occasionally, researchers will give patients undergoing a mri an injection of a substance called gadolinium. gadolinium works by brightening areas of the magnetic resonance image, thereby improving the contrast. in this study researchers will use magnetic resonance imaging and contrast substances, like gadolinium, on normal volunteers in order to evaluate different aspects of its performance. information gathered from this study may be used to develop more specific research studies involving mri.

technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. these studies will be conducted in the mri systems located at the nih. these studies may involve the intravenous administration of commercially available mr contrast media and exercise. the results will be used to evaluate the performance of various pulse sequences, gradient coils, and rf coils on human subjects and will provide essential ground work for specific patient protocols.

Eligibility criteria:
* inclusion criteria: any normal volunteer greater than or equal to 18 who is capable of giving informed consent. exclusion criteria: a subject will be excluded if he/she has a contraindication to mr scanning such as: 1. brain aneurysm clip 2. implanted neural stimulator 3. implanted cardiac pacemaker or defibrillator 4. cochlear or ear implant 5. ocular foreign body (e.g. metal shavings) 6. insulin pump 7. pregnant women (when uncertain, subject will undergo urine or blood testing). 8. claustrophobia 9. any condition in the principal investigator's judgement which present unnecessary risk exclusion criteria for gadolinium enhanced studies: 1. lactating women 2. renal or hepatic disease

Keywords: imaging spectroscopy mri cardiovascular technical development heart safety toxicity gadolinium adverse events normal volunteer
manta™ versus suture-based closure after transcatheter aortic valve implantation trial

Conditions: Aortic Valve Stenosis

Summary: to investigate whether the collagen-based manta vascular closure device (vcd) is superior to suture-based vcds in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.

see summary

Eligibility criteria:
inclusion criteria: * patients undergoing elective transfemoral tavi for severe aortic valve stenosis with any commercially-available transcatheter heart valve (thv) * common femoral artery diameter \> 5.0mm (14 - 22f compatible) exclusion criteria: * symptomatic leg ischaemia * previous thromboendarterectomy or plastic patch of the common femoral artery * previous implantation of a suture-based vcd less than 30 days before, or a plug-based vcd within 6 months * unilateral or bilateral lower extremity amputation * systemic infection or a local infection at or near the access site * allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel) * active bleeding or bleeding diathesis including thrombocytopenia (platelet count \<50,000 cells/ul), thrombasthenia, hemophilia, or von willebrand disease * patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with inr \>1.8 at the time of the procedure * patient unable to be adequately anti-coagulated for the procedure * morbidly obese or cachectic (bmi \>40 kg/m2 or \<20 kg/m2) * anatomical and procedural contraindication for suture-based or manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease) * absence of computed tomographic data of the access site before the procedure * patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease * known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory) * participating in trials in which the primary endpoint includes bleeding or vascular complications

Keywords: vascular closure devices transcatheter aortic valve implantation
cyclophosphamide, fludarabine and antithymocyte globulin conditioning in myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome

Summary: to evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (cyfluatg) for allogeneic hematopoietic cell transplantation (hct) in patients with lower risk myelodysplastic syndrome (mds).

conditioning therapy * cytoxan 50 mg/kg/d on d-3 to -2 * fludarabine 30 mg/m2 on d-6 to -2 * antithymocyte globulin (atg; thymoglobulin®) 1.5 mg/kg/d (for hla-matched sibling donor hct) or 3.0 mg/kg/d (for other alternative donor hct) * methylpd 2 mg/kg/d on d-4 to -1 mobilization and harvest * g-csf 10 mcg/kg/d s.c. on d-3 to 0 * harvest of pbmcs on d 0 to +1 donor g pbmc infusion * infuse g-pbmcs on d 0 to d+1. gvhd prophylaxis * cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. tapered beginning between d+30 and d+60. * methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7 preemptive dose-escalating dlis * begin at d+120 or at least 2 wks after ist discontinuation. * failure to achieve full donor chimerism no evidence of gvhd * cd3+ cell dose increment q 4 wks -+ cell dose: hla-matched donor hct (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), hla-matched unrelated donor hct (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), hla-matched familial donor hct (1 x 105/kg, 5 x 105/kg, 1 x 106/kg)

Eligibility criteria:
inclusion criteria: * patients with lower risk mds (bone marrow blast percentage \< 5%) * patients with appropriate hematopoietic cell donor * adequate performance status (karnofsky score of 70 or more; see appendix ii) * adequate hepatic and renal function (ast, alt, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dl). * adequate cardiac function (left ventricular ejection fraction of 40% or more on heart scan or echocardiogram) * signed and dated informed consent must be obtained from both recipient and donor. exclusion criteria: * presence of significant active infection * presence of uncontrolled bleeding * any coexisting major illness or organ failure * patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia) * patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * nursing women, pregnant women, women of childbearing potential who do not want adequate contraception

Keywords: mds